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Wound HealNCT04805463

Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.

A study testing PRF group, CGF group and AFG group in people with Wound Heal and Gingival Overgrowth, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. Read more about this study

Who is it for?
Ages 12 to 65 yearsHealthy volunteers can take part
What is being tested?
PRF group, CGF group and AFG group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 30 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients who are systemically healthy, have chronic inflammatory gingival enlargement in the maxillary and mandibular anterior region, and who do not have attachments and bone loss in clinical and radiographic evaluation.

Who cannot join

  • Patients with a history of periodontal treatment in the last 6 months, smokers, those using drugs that may cause gingival enlargement, and pregnant or breastfeeding women were excluded.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Periodontology, Faculty of Dentistry, Inonu University

    Malatya, Battalgazi, 44280

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of PRF, CGF and AFG Application on Wound Healing Following Gingivectomy and Gingivoplasty Operations: a Randomized Controlled Clinical Trial

The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. The postoperative PRF, CGF, and AFG applied areas were compared with the control regions. 0th,7 th,14 th and 28 th on the days, the surgical area was painted with mira-2-tone solution and evaluated in the ImageJ program. Measurements of clinical periodontal parameters including PI, GI, SC and SD were recorded at the beginning, after IPT and 28 days after the operation. Wound healing was evaluated with H2O2 test, VAS-Pain, and LTH index on 7th, 14th and 28th days. The patients were asked to evaluate their aesthetic perceptions on the VAS aesthetic scale.

Read the detailed description

Study design and patient selection

In this randomized, controlled, split-mouth (lower, upper jaw, right and left anterior regions) clinical study, who applied to İnönü University Faculty of Dentistry Department of Periodontology between January 2020 and May 2020, due to gingival problems, chronic examination was performed. included individuals diagnosed with inflammatory gingival enlargement.

All patients received initial periodontal therapy (BPT). The patients were called for control after 2 weeks and surgery was planned for the patients who provided adequate oral hygiene. In our study, the vertical DM index, first described by Goaz and Angelopoulos, and later modified by Damm and Miller (DM), was used to classify the gingival enlargement in the vertical direction (1). In order to classify the bucco-lingual gingival growths in the interdental papillae, the horizontal MB index, first described by Seymour et al. And later modified by Miranda and Brunet (MB), was used (2). As a result of the measurements made, grades other than score 0 according to the DB and MB indices were accepted as having gingival enlargement. The distribution of control (n = 19) and three test groups (n = 19, n = 19, n = 19) after gingivectomy and gingivoplasty was randomized (block randomization).

Clinical Measurements

In clinical periodontal evaluation, plaque index (PI) (3), gingival index (GI) (4), bleeding on probing (SC) and probing depth (SD ) measurements were performed at baseline (T0), after BPT (T1) and on the 28th day (T2) after gingivectomy and gingivoplasty operation. Measurements were made in a total of 6 regions of all teeth: mesio-buccal, mid-buccal, disto-buccal, disto-lingual / palatinal, mid-lingual / palatinal and mesio-lingual / palatinal. Clinical periodontal measurements of all teeth of the individuals included in the study were performed by a single investigator (E.B.).

Gingivectomy and gingivoplasty

Before surgery, all patients were gargled with 0.12% chlorhexidine for 1 minute. The incision lines were determined by applying infiltrative anesthesia (Maxicaine Fort) to the areas to be operated, and the external bevel incision was performed with a # 15 scalpel (Broche® Medical scalpel tip; carbon steel) and a Kirkland blade (Hu-Friedy, Chicago, IL, USA). Orban blade (Hu-Friedy, Chicago, IL, USA) was used in the interproximal areas. After the incision was completed, the remaining gum pieces were removed with the help of periodontal curette and microsurgical scissors (Hu-Friedy, Chicago, IL, USA). Then gingivoplasty was performed. After gingivectomy and gingivoplasty, the control areas were left to recover spontaneously. PRF, CGF and AFG were applied to the test areas. Surgical areas in control and test areas were covered with a periodontal pat (Coe-Pak, lsip, IL, USA).

Preparation of platelet-rich fibrin membrane

Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. The collected venous blood was placed in the PC-02 (Process, Nice, France) centrifuge device and centrifuged at 3000 rpm for 10 (400xg) minutes (5). The obtained PRF was taken out of the tube, placed in the PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. The prepared PRF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.

Preparation of concentrated growth factor membrane

Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. These tubes were then centrifuged in a centrifuge device (Medifuge; Silfradent srl, Sofia, Italy) using a program with the following features: acceleration for 30 seconds followed by 2 minutes (692xg) at 2700 rpm, 4 minutes (547xg) at 2400 rpm, 2700 rpm. Centrifugation for 4 minutes (592xg) at 3000 rpm for 3 minutes (855xg) and finally deceleration for 36 seconds (6). After centrifugation, CGF was taken from the middle part of the tube, placed in PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. Prepared CGF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.

Preparation of autologous fibrin glue

Venous blood taken from the patient was transferred to a 9 ml glass-covered plastic tube (Vacuette serum tubes, Greiner Bio-one) that did not contain any anticoagulants. Sohn et al. In the protocol he recommended (7), the venous blood collected in the tube was centrifuged in a centrifuge device (Medifuge, Silfradent, Italy) at 2700 rpm (approximately 692 g) for 2 min. AFG obtained from the upper part of the tube after centrifugation was collected with the help of an injector and transferred to the metal body. The polymerization was allowed for 15-20 minutes. After polymerization was completed, AFG was applied to the surgical operation area and the operation area was covered with a periodontal pat.

Post Operative Care and Suggestion

Patients were advised to protect the wound area with periodontal pats from trauma, not to consume too hot and too cold foods, and to eat soft foods. It was stated that the pat should be kept in the mouth for 1 week, and if the pat was damaged during this period, they should apply to our clinic immediately. Patients were prescribed paracetamol-containing analgesic (Parol 500 mg) and a mouthwash containing 0.12% chlorhexidine to use three times a day for a week. The patients were only advised not to brush their teeth in the operation area for 1 week. It was stated that he should provide oral hygiene in areas that were not operated. They were advised to use an extra soft toothbrush in the area after the pat was removed.

Surface area determination

Mira-2-tone, a plaque staining agent (GMBH \& Co., Duisburg, Germany), was used to detect wound surface epithelization at baseline, postoperative 7, 14, and 28 days. Standardized photographs were taken from each patient to evaluate the dark stained areas after staining with Mira-2-tone in the gingiva where epithelialization was not completed and wound healing continued. During the photo shoot, the patients were seated upright and facing straight ahead. All photos were taken by a single person on the same camera (Nikon Coolpix 4500, Tokyo, Japan), at the same distance (20 cm) and light values (ISO-800). The photo size was scaled by using a 10 mm Williams periodontal probe during the photo taking. Wound surface epithelization was calculated using Image J software program (National Institutes of Health, USA ImageJ 1.48V) from the photographs obtained. Each measurement step was done by the same researcher (E.B.) each time. The calibration of the person who made the measurements was performed by repeating the wound surface epithelialization area measurement at one-week intervals on the photo images of 10 patients who had undergone gingivectomy and gingivoplasty surgery and were not included in the study. In these two separate evaluations, the calculations were 95% compatible.

Epithelialization test

In order to evaluate the wound surface epithelization during the healing process, 3% H2O2 was applied to the surface of the operation area with the help of an injector. As a result of the decomposition of H2O2 into water and oxygen through the catalase enzyme released by the blood cells present in the wound area, it was evaluated as "epithelization incomplete" if foaming was observed with oxygen formation, and "epithelization completed" if foaming was not observed . H2O2 test was performed at the controls on the 7th, 14th and 28th days after the operation.

Healing index Landry, Turnbull, and Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration (8). The wound healing process with LTH index was performed at the postoperative 7th, 14th and 28th days.

Postoperative pain and aesthetic

VAS was used for postoperative pain and aesthetic evaluation (9). The patient's 7th, 14th He was asked to evaluate the level of pain he felt from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale in the control sessions on the 28th and 28th days. In the control session on the 28th day, the patients were asked to evaluate their aesthetic perceptions from 1 to 10 according to the VAS-Aesthetics (1: dissatisfied, 10: very satisfied) scale.

Being tested
Control group, PRF group, CGF group, AFG group
Keywords
Autologous fibrin glue, Concentrated growth factor, Gingivectomy, Gingivoplasty, Platelet rich fibrin
Medical subject headings
Gingival Overgrowth, Gingival Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupOther

    The group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area.

  • PRF groupOther

    The group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF.

  • CGF groupOther

    The group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF.

  • AFG groupOther

    The group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG.

Study groups in NCT04805463
Study groupRoleWhat they receive
control groupExperimentalAfter gingivectomy and released into the secondary wound healing gingivoplasty group.
Receives: Other: Control group
PRF groupExperimentalThe group in which PRF was applied to the wound surface after gingivectomy and gingivoplasty.
Receives: Other: PRF group
CGF groupExperimentalThe group in which CGF was applied to the wound surface after gingivectomy and gingivoplasty.
Receives: Other: CGF group
AFG groupExperimentalThe group in which AFG was applied to the wound surface after gingivectomy and gingivoplasty.
Receives: Other: AFG group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of non-epithelialized areas on the wound surface

    Mira-2 tone solution was used to identify non-epithelialized areas on wound surfaces after gingivectomy and gingivoplasty. Mira-2 tone was applied to the wound surfaces and dark dyed areas were calculated as mm2 in Image j program.

    Measured: Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.

  2. Epithelialization test

    H2O2 was used to identify non-epithelialized areas. If bubbling is observed after the application of H202 to the wound surface, epithelialization was incomplete, if bubbling was not observed, epithelialization was recorded as completed.

    Measured: The change in wound surface epithelization was evaluated on the 7th, 14th and 28th days postoperatively.

  3. Healing index

    Landry, Turnbull, Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration, was evaluated.

    Measured: Wound healing evaluation with LTH index was performed at the postoperative 7th, 14th and 28th day controls.

  4. Postoperative pain

    VAS was used for postoperative pain assessment. The patients were asked to evaluate the level of pain from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale during the control sessions.

    Measured: Evaluation of VAS-Pain change on postoperative 7th, 14th and 28th days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start1 Jan 2020
  3. Primary completion30 Apr 2020
  4. Study completion30 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Split mouth design was used in the study. The chin was divided into lower, upper and right, and left anterior regions. The distribution of the platelet concentrate and control group to be used after gingivectomy and gingivoplasty was randomly decided.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805463
Sponsor's protocol ID
2019/216
Status last verified
Mar 2021
First submitted
16 Mar 2021
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have other studies using this data.

Publications

  • Miranda J, Brunet L, Roset P, Berini L, Farre M, Mendieta C. Prevalence and risk of gingival enlargement in patients treated with nifedipine. J Periodontol. 2001 May;72(5):605-11. doi: 10.1902/jop.2001.72.5.605.

    PubMed 11394395
  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PubMed 14158464
  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PubMed 14121956
  • Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.

    PubMed 16504850
  • Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scari G, Sacco L, Batani T, Rezzani R. Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction. Microsc Res Tech. 2011 Aug;74(8):772-7. doi: 10.1002/jemt.20968.

    PubMed 21780251
  • Sohn D-S, Huang B, Kim J, Park WE, Park CC. Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix (Sticky bone) and CGF-enriched fibrin membrane in Implant Dentistry. J Implant Adv Clin Dent. 2015;7:11-29.

  • Landry RG. Effectiveness of Benzydamine HC1 in the Treatment of Periodontal Post-surgical Patients: Faculty of Dentistry, University of Toronto; 1985.

  • Crichton N. Visual analogue scale (VAS). J Clin Nurs. 2001;10(5):706-6

  • Miller CS, Damm DD. Incidence of verapamil-induced gingival hyperplasia in a dental population. J Periodontol. 1992 May;63(5):453-6. doi: 10.1902/jop.1992.63.5.453.

    PubMed 1527689

Questions about this trial

What is this clinical trial studying?

A study testing PRF group, CGF group and AFG group in people with Wound Heal and Gingival Overgrowth, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of non-epithelialized areas on the wound surface (time frame: Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805463, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.

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